Tool and set screw for use in spinal implant systems

ABSTRACT

The present invention relates to a tool in combination with a set screw for use in spinal implant systems, and more particularly to a tool for the deployment of set screws with a break-off neck portion comprising a handle portion, a stem portion extending from the handle portion, a set screw retaining means, and a driving means extending from the stem portion and disposed opposite the handle portion. The driving means is adapted to allow the installation of the set screw to the bone and applying torque for the shearing of the neck portion thereof, and at the same time is adapted to remove the installed screw portion of the said set screw when needed.

This application claims the benefit of priority to copending U.S.Provisional Patent Application Ser. No. 61/354,436, entitled “A TOOL ANDSET SCREW FOR USE IN SPINAL IMPLANT SYSTEMS”, filed Jun. 14, 2010, theentire disclosure of which is hereby incorporated by reference as ifbeing set forth herein in its entirety.

TECHNICAL FIELD

The present invention relates in general to spinal implant systems, butmore particularly to a tool adapted for the deployment of set screwswith a break-off neck portion featuring a means to allow theinstallation of the set screw to a spinal bone screw or hook andapplying torque for the shearing of the neck portion thereof, and at thesame time adapted to remove the installed screw portion of the set screwfrom the bone screw or hook.

BACKGROUND OF THE INVENTION

Existing spinal implant systems employ various instrumentations tosecure, adjust and remove the self-limiting set screws to a bone screwor a hook. Tools such as set screw holders, break-off screw drivers, andset screw removal screw drivers are used separately in various stages ofthe implantation procedure. Such tools are made and dedicated only for aparticular stage in the implanting process. Generally, the implantationprocedure involves the following steps, namely:

-   -   1. Receiving and installing a corresponding set screw to the        bone screw or hook;    -   2. Applying the required amount of torque to the set screw to        shear off the head portion thereof and tighten the screw on the        bone screw or hook; and    -   3. Removing the set screw, when required, from the bone screw or        hook after the installation thereof.

The present spinal implants systems are expensive, tedious and longer toadminister since each of the aforementioned general steps requirespecific and dedicated tools to achieve the desired objectives.

Although various features have been incorporated to existinginstrumentations for implant purposes, a single tool that is simple inits construction and is easy to use is necessary to solve theaforementioned drawbacks and difficulties presented by existing spinalimplant systems.

SUMMARY OF THE INVENTION

The proposed invention seeks to simplify and solve the existing toolingproblems in present spinal implant systems by providing a single tooland in combination with a self-limiting set screw for spinal implantsystems. The tool is dedicated and solely adapted to be used for all thefollowing spinal implant procedures, namely: (a) receiving andinstalling a corresponding set screw to the bone screw or hook; (b)applying the required amount of tightening torque to the set screw; andfinally (c) removing the set screw from the bone screw or hook after theinstallation thereof. Unlike in existing spinal implant systems, onlyone tool is used in the procedures for installing, tightening, andremoving the set screw from the bone screw or hook.

It is, therefore, the main object of the present invention to provide asingle tool in combination with a set screw to solve the technicalproblem of avoiding the very the tedious procedure of using differenttools in the spinal implant system.

More particularly, the present invention provides for a tool with a setscrew for use in spinal implant systems, said tool comprising a handle,a stem extending from said handle, a first protrusion extending axiallyfrom the end portion of said stem opposite said handle and reducedsecond protrusion extending axially from said first protrusion, saidfirst and second protrusions being provided with a plurality of adjacentsubstantially V-shaped projections formed along the surfaces thereofadapted to engage with internal V-shaped notches of said set screw, saidstem being provided with at least one flexible arm formed along thelower portion thereof and proximate said first protrusions, saidflexible aim having an outwardly directed flange portion formed at thetip thereof to interlock with said set screw, said set screw comprisinga body formed with an axial bore and having a head portion, a neckportion and a threaded screw portion extending from said neck portion,said head portion having a internal peripheral notch formed at the upperportion thereof and a plurality of substantially V-shaped internalnotches formed along the surface thereof, and said threaded screwportion having an external thread and a plurality of substantiallyV-shaped internal notches formed along the surface thereof.

These and other objects and advantages of the present invention willbecome more apparent upon a reading of the ensuing detailed descriptiontaken in conjunction with the appended drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a sectional view showing the tool and corresponding set screwof the present invention in detached position;

FIG. 2 is a sectional view showing the tool and corresponding set screwof the present invention in engaged position;

FIG. 3 is a sectional perspective view of the tool and corresponding setscrew of the present invention;

FIG. 4 is another side view showing the tool and corresponding set screwof the present invention; and

FIGS. 5 and 6 are perspective views showing the tool and correspondingset screw of the present invention.

FIG. 7 is a sectional view showing an alternative embodiment of thepresent invention.

DETAILED DESCRIPTION

It is to be understood that the phraseologies and terminologies usedherein are for the purposes of description and should not be regarded aslimiting.

Referring now to the different views of the drawings, wherein likereference numerals designate the steps, components or elementsthroughout the ensuing enabling description, the present inventionprovides for a tool for use in spinal implant systems adapted for thedeployment of set screws with a break off head designated as 10.

As shown in FIGS. 1 & 3, the tool 10 comprises a handle portion 11, astem portion 12 extending from the handle portion 11 and a driving means“D” provided on the tool 10, particularly extending from the stemportion 12 and disposed opposite handle portion 11. A corresponding setscrew 13 is provided to engage with the tool 10 to connect the bonescrew or hook and spinal rod in the implant system, and comprising ahead portion 14, a break-off neck portion 15 and a preferably reducedthreaded screw portion 16 extending from the head portion 14. Set screw13 is formed by an axial bore 13 a and extending to a reduced axial bore13 b at the screw portion 16. Screw portion 16 is also formed withexternal screw thread 16 a and head portion 14 is formed with aninternal peripheral notch 14 a formed at the upper portion thereof.

Referring now to FIG. 2, the driving means “D” is adapted to allow theinstallation of the set screw 13 to the bone screw or hook and applyingtorque for the shearing of the neck portion 15 thereof, andsimultaneously adapted to remove the installed screw portion 16 on thebone screw or hook after the installation thereof.

Driving means “D” comprises a first protrusion 17 extending axially fromthe end portion of the stem portion 12 opposite the handle portion 11,and a reduced second protrusion 18 extending axially from the firstprotrusion 17. The diameter of the first protrusion 17 is such that itis sized to conform within the inner diameter of axial bore 13 a, andlikewise the second protrusion 18 has a diameter sized to conform to theinner diameter of axial bore 13 b of the set screw 13. The first andsecond protrusions 17 & 18 are further provided with corresponding firstlocking means “A”, and a corresponding second locking means “B” isprovided along the axial bores 13 a & 13 b of set screw 13. The firstand second locking means “A” and “B” are provided to engage the tool 10to the set screw 13. Furthermore, a retaining means “R” is provided onthe stem portion 12 to allow the handling and installation of the setscrew 13 on a bone screw or hook prior to shearing of the neck portion15 thereof.

As shown in the drawings, particularly in FIG. 3, the first lockingmeans “A” comprises a plurality of adjacent substantially V-shapedprojections 19, 19′ formed along the surfaces of the first and reducedsecond protrusions 17 & 18, and the second locking means “B” comprisesthe corresponding plurality of adjacently disposed substantiallyV-shaped notches 20, 20′ formed along the internal surfaces of headportion 14 and the screw portion 16 of the set screw 13, respectively

The retaining means “R” comprises at least one flexible arm 21 formedproximate along the side portion of the stem portion 12 defining a gap“G” between the stem portion 12 and the flexible arm 21, and flexiblearm 21 is also disposed proximate the first protrusion 17. The flexiblearm 21 has an outwardly directed flange portion 22 formed at the tipthereof. The flange portion 22 is adapted to interlock with theperipheral notch 14 a of the head portion 14 when the set screw 13 is tobe installed in the bone screw or hook. The gap “G” allows the flexiblearm 21 to be flexed inwardly towards the side of the stem portion 12when the flange portion 22 is interlocked with the peripheral notch 14a.

As shown in FIGS. 1 & 3, first protrusion 17 is substantially largerthan second protrusion 18. It is known in the art that the tighteningtorque for a set screw is higher than the loosening torque. The largerdimensions of protrusion 17 allow it to shear off the head portion 14 ofsetscrew 13 at the break-off neck portion 15. The smaller dimensions ofsecond protrusion 18 prevent it from engaging the V-shaped notches 20,protecting it from excessive torque during tightening. In existingimplant systems, the tool used for tightening the set screw by abreak-off feature usually cannot be used for loosening the set screwbecause of its large dimensions. On the other hand, the tool used forloosening the set screw cannot be used for tightening by break-offbecause it is not strong enough due to its small dimensions.

In operation, the tool 10 is first engaged to the set screw 13 byinserting the first protrusion 18 within the axial bore 13 a of the headportion 14 as shown in FIG. 2. The flange portion 22 of the flexible arm21 is adapted to seat on the peripheral notch 14 a of the head portion14 as to retain the set screw 13 in a stable and controllable manner inpreparation for its surgical attachment to the bone screw or hook. Thefirst protrusion 17 is interlocked within the axial bore 13 a by theengaging of the V-shaped projections 19 with the corresponding V-shapednotches 20. In this particular position, the reduced second protrusion18 is also held within the axial bore 13 a as shown in FIG. 2, but isnot engaged to any portion of set screw 13. The engaging relationship ofthe V-shaped projections 19 with the corresponding V-shaped notches 20easily facilitates connecting the set screw to the bone screw or hook,and further imparts a controlled amount of torque in breaking the neckportion 15 of the set screw 13. After installing the set screw 13, thehead portion 14 is sheared from the screw portion 16 and the same iseasily removed from the tool 10 by inwardly pressing the flexible arm 21to release the flange portion 22 away from the peripheral notch 14 aand, finally, pulling the head portion 14 from the tool 10.Alternatively, the head portion 14 can be removed from the tool 10 byexerting sufficient pulling force without pressing the flexible arm 21.The installed screw portion 16 can be later removed if necessary fromthe bone screw or hook by using the same tool 10. To uninstall the screwportion 16, the reduced second protrusion 18 of the tool 10 is simplyengaged with the axial bore 13 b thereof via engaging the V-shapedprojections 19′ with the V-shaped notches 20′.

In another embodiment according to the present invention as shown inFIG. 7, the first protrusion 17 of FIG. 3 is replaced by a cavity 31extending inward from the end portion of stem portion 12′ opposite thehandle portion 11′. Said cavity 31 is provided with a plurality ofadjacent substantially V-shaped internal notches 32 formed along thesurface thereof to engage with corresponding V-shaped projections 33 onsetscrew 30.

Set screw 30 is further provided with an external peripheral notch 34formed at the upper portion thereof. Correspondingly, tool 10′ isprovided with a flexible arm 35 with an inwardly facing flange 36 formedat the tip thereof. The flange portion 36 is adapted to interlock withthe peripheral notch 34 when the set screw 30 is to be installed in thebone screw or hook.

The present invention also discloses a method for installing, tighteningand loosening a set screw on a spinal bone screw or hook, using a singletool, more particularly, the herein tool and set screw as previouslydescribed. The method comprising the steps of: providing a tool having ahandle portion and a stem portion extending from said handle portion,said tool having a retaining means and a driving means for a set screw;

-   -   providing a set screw having an axial bore, a head portion, a        break-off neck portion and a threaded screw portion extending        from said neck portion; attaching and retaining said set screw        on said tool; tightening the set screw on a spinal bone screw or        hook by shearing off the head portion of said set screw at the        break-off neck portion using said tool; removing the sheared off        head portion from said tool; and loosening, when needed, the        threaded screw portion of said set screw from the spinal bone        screw or hook using said tool.

Additional advantages and modifications of the present invention willreadily occur to those skilled in the art in view of these teachings.The present invention in its broader aspects is not limited to thespecific details, representative contrivances, and illustrative examplesshown and described herein. Accordingly, various modifications may bemade without departing from the spirit and scope of the general conceptas defined in the appended claims and their equivalents.

1-12. (canceled)
 13. In combination, a tool with a set screw for use inspinal implant systems, comprising: a tool having a handle portion and astem portion extending from said handle portion; a set screw having anaxial bore, a head portion, a break-off neck portion and a threadedscrew portion extending from said neck portion, wherein said headportion comprises a plurality of substantially V-shaped internal notchesformed along the surface thereof, and wherein said threaded screwportion comprises an external thread and a plurality of substantiallyV-shaped internal notches formed along the surface thereof; a retainingmeans provided on said tool to allow handling and installation of saidset screw; and a driving means provided on said tool to allow theinstallation of said set screw to a bone screw or hook, apply torque forthe shearing of the neck portion of said set screw, and remove theinstalled screw portion of said set screw on said bone screw or hook.14. In combination, a tool with a set screw for use in spinal implantsystems according to claim 13, wherein said driving means comprising afirst protrusion extending axially from the end portion of said stemportion opposite said handle portion, and a reduced second protrusionextending axially from said first protrusion, said first protrusionbeing provided with a plurality of substantially V-shaped projections toengage with said internal V-shaped notches in head portion of said setscrew, and said second protrusion being provided with a plurality ofadjacent substantially V-shaped projections formed along the surfacesthereof to engage with said internal V-shaped notches in threaded screwportion of said set screw.
 15. In combination, a tool with a set screwfor use in spinal implant systems, comprising: a tool having a handleportion and a stem portion extending from said handle portion; a setscrew having an axial bore, a head portion, a break-off neck portion anda threaded screw portion extending from said neck portion, wherein saidhead portion comprises a plurality of substantially V-shaped externalprojections formed along the surface thereof, and wherein said threadedscrew portion comprises an external thread and a plurality ofsubstantially V-shaped internal notches formed along the surfacethereof; a retaining means provided on said tool to allow handling andinstallation of said set screw; and a driving means provided on saidtool to allow the installation of said set screw to a bone screw orhook, apply torque for the shearing of the neck portion of said setscrew, and remove the installed screw portion of said set screw on saidbone screw or hook.
 16. In combination, a tool with a set screw for usein spinal implant systems according to claim 15, wherein said drivingmeans on said tool comprising a cavity extending axially from the endportion of said stem portion opposite said handle portion, and a reducedprotrusion extending axially from said cavity, said cavity beingprovided with a plurality of adjacent substantially V-shaped internalnotches formed along the surface thereof to engage with said externalV-shaped projections on said set screw, and said reduced protrusionbeing provided with a plurality of adjacent substantially V-shapedprojections formed along the surface thereof to engage with saidinternal V-shaped notches in said set screw.
 17. A method of installing,tightening and loosening a setscrew on a spinal bone screw or hook,comprising the steps of: providing a tool having a handle portion and astem portion extending from said handle portion, said tool having aretaining means and a driving means for a set screw; providing a setscrew having an axial bore, a head portion, a break-off neck portion anda threaded screw portion extending from said neck portion, wherein saidhead portion comprises one of a plurality of substantially V-shapedinternal notches and a plurality of substantially V-shaped externalprojections formed along the surface thereof, and wherein said threadedscrew portion comprises an external thread and a plurality ofsubstantially V-shaped internal notches formed along the surfacethereof; attaching and retaining said set screw on said tool; tighteningthe set screw on a spinal bone screw or hook by shearing off the headportion of said set screw at the break-off neck portion using said tool;removing the sheared off head portion from said tool; and loosening,when needed, the threaded screw portion of said set screw from thespinal bone screw or hook using said tool.